Rx Item-Dexrazoxane 500MG 1 Single Dose Vial by Breckenridge Totect, Zinecard

Rx Item-Dexrazoxane 500MG 1 Single Dose Vial by Breckenridge Institutional , Clinical Information:
Generic Code And Description: 36426 Dexrazoxane Hcl Intravenous Vial 500 Mg
Strength: 500 Mg
Dose Form: Vial (Ea)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 92560000 Protective Agents
Active Ingredients: 7168 Dexrazoxane Hcl 149003010
Inactive Ingredients: Drug Class: Drug Class: 92560000 Protective Agents , OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 1 , Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:1 , Item Strength Code:500MG , Item Abbreviation: Dexrazoxane , Generic Form: Vial


These highlights do not include all the information needed to use DEXRAZOXANE FOR INJECTION safely and effectively. See Full Prescribing Information for DEXRAZOXANE FOR INJECTION.

DEXRAZOXANE for injection for intravenous use
Initial U.S. Approval: 1995
INDICATIONS AND USAGE

Dexrazoxane for Injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use Dexrazoxane for Injection with doxorubicin initiation. (1)
DOSAGE AND ADMINISTRATION

Reconstitute vial contents and dilute before use. (2.3)
Administer Dexrazoxane for Injection by intravenous infusion over 15 minutes.
DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. (2.1, 2.3)
The recommended dosage ratio of Dexrazoxane for Injection to doxorubicin is 10:1 (e.g., 500 mg/m2 Dexrazoxane for Injection to 50 mg/m2 doxorubicin). Do not administer doxorubicin before Dexrazoxane for Injection. (2.1)
Reduce dose by 50% for patients with creatinine clearance <40 mL/min. (2.2, 8.7)

DOSAGE FORMS AND STRENGTHS

500 mg single dose vials as sterile, pyrogen-free lyophilized. (3)
CONTRAINDICATIONS

Dexrazoxane for Injection should not be used with non-anthracycline chemotherapy regimens. (4)
WARNINGS AND PRECAUTIONS

Myelosuppression: Dexrazoxane for Injection may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. (5.1)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise female patients of reproductive potential of the potential hazard to the fetus. (5.5, 8.1)

ADVERSE REACTIONS

In clinical studies, Dexrazoxane for Injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving Dexrazoxane for Injection versus placebo. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS

Nursing Mothers: Discontinue drug or nursing. (8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2021
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Rx Item-Dexrazoxane 500MG 1 Single Dose
Item No. RX698795, 698795, NDC No.: 51991-0942-98, 51991-942-98, 5199194298, 51991094298, 0942-98, 094298 UPC No. 3-51991-94298-6, 351991-942986, 351991942986

Rx Item-Dexrazoxane 500MG 1 Single Dose
Item No. RX698795, 698795, NDC No.: 51991-0942-98, 51991-942-98, 5199194298, 51991094298, 0942-98, 094298 UPC No. 3-51991-94298-6, 351991-942986, 351991942986

Rx Item-Dexrazoxane 500MG 1 Single Dose
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica